UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030880 |
|---|---|
| Receipt number | R000035249 |
| Scientific Title | Examination of 1 week continuous ingestion of drink containing plant extract. A-18001 |
| Date of disclosure of the study information | 2018/01/22 |
| Last modified on | 2018/07/19 16:30:06 |
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Basic information
Public title
Examination of 1 week continuous ingestion of drink containing plant extract. A-18001
Acronym
Examination of 1 week continuous ingestion of drink containing plant extract. A-18001
Scientific Title
Examination of 1 week continuous ingestion of drink containing plant extract. A-18001
Scientific Title:Acronym
Examination of 1 week continuous ingestion of drink containing plant extract. A-18001
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of plant extract on vascular function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin temperature before and after 1day drink ingestion.
Key secondary outcomes
Peripheral blood flow and subjective evaluation.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drink containing plant extract (1 week continuous ingestion)->washout period->placebo drink not containing plant extract (1 week continuous ingestion)
Interventions/Control_2
Placebo drink not containing plant extract (1 week continuous ingestion)->washout period->Drink containing plant extract (1 week continuous ingestion)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy adults
2.Person whose estradiol cycle is stable between 28 and 32 days.
3.Person who is sensitive to cold.
4.Person who agrees not to ingest specified foods and supplements during the test period.
Key exclusion criteria
1.Person whose body math indexes are less than 18.5 or more than 25.0.
2.Person whose diastolic blood pressures are more than 90mmHg and systolic ones are more than 140mmHg.
3.Person who has severe allergic disease as rhinitis, atopicdermatitis.
4.Person who is pregnant, lactating or planned to become pregnant during the test period.
5.Patient with vascular function disorder.
6.Person who has problems with electrocardiogram test such as arrhythmia.
7.Person who takes medicine.
8.Person who regularly goes to hospital or went to the medical institution within a month.
9.Current smoker.
10.Person who plans to participate in the other clinical studies.
11.Person who is judged as unsuitable for the study by the investigator for other reasons.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akane Suma |
Organization
Kao Corporation
Division name
R&D-Skin Care Products Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
+81-3-5630-9581
suma.akane@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Shimizu |
Organization
Kao Corporation
Division name
R&D-Skin Care Products Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
+81-465-35-3175
Homepage URL
shimizu.norio@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
SOUKEN Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 18 | Day |
Last modified on
| 2018 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035249
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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